| NCT ID | NCT05513508 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Azienda Ospedaliero Universitaria Maggiore della Carita |
| Condition | Pressure Ulcer |
| Study Type | INTERVENTIONAL |
| Enrollment | 478 participants |
| Start Date | 2022-12-08 |
| Primary Completion | 2027-09 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 478 participants in total. It began in 2022-12-08 with a primary completion date of 2027-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
In this trial investigators will explore if a protocolized rotational use of interfaces i.e., masks, during noninvasive positive pressure ventilation (NPPV) compared to standard care is clinically effective and cost-effective in reducing the incidence of pressure sores in patients with hypercapnic acute respiratory failure (AHRF) treated continuously i.e., for more than 24 hours, with NPPV (to avoid intubation, as alternative to invasive ventilation and after early extubation and weaning).
Eligibility Criteria
Inclusion Criteria: * Age\>18 years old * Patients with chronic obstructive pulmonary disease (COPD) exacerbation or with AHRF of a different etiology needing NPPV to avoid intubation (pH \< 7.35 with PaCO2 \> 45 mmHg and partial pressure of oxygen (PaO2) \< 65 mmHg plus respiratory rate \> 25 breath/min with clinical signs of respiratory muscle distress); or as alternative to invasive ventilation with a forecast of treatment of at least 24 hours admitted to the intensive care unit, intermediate respiratory care unit, respiratory medicine service or internal medicine service according to hospital organization; or patients with chronic pulmonary disease intubated for a COPD exacerbation or for pneumonia who are early extubated and weaned in the intensive care unit with NPPV with a forecast of treatment of at least 24 hours. Exclusion Criteria: * Patient with skin breakdown or non-blanchable erythema in one of the following areas i.e., nasal bridge, nasolabial fold, cheek or scalp at hospital entrance; * Patients who refuse to consent to the study protocol; * Patient known to be pregnant; * Patients with contraindication to NPPV (lack of spontaneous breathing; gasping; anatomical or functional airway obstruction; gastrointestinal bleeding or ileus; coma; massive agitation; massive retention of secretions despite bronchoscopy and aggressive physiotherapy; hemodynamic instability (cardiogenic shock, myocardial infarction); status post upper gastrointestinal surgery); * Patients entering hospital with asthma, with cardiogenic pulmonary edema; * Patients with tracheostomy; * Patients needing NPPV only for palliation of symptoms (relief of dyspnea) i.e., category 3 defined by the Task Force on the Palliative Use of NPPV of the Society of Critical Care Medicine; * Use of high flow nasal cannula integrated with NPPV for weaning strategy; * Pre-existing skin erythematosus diseases; * Known hypersensitivity to skin protective devices (i.e., polyurethan films, colloids, foams); * More than 2 hours of NPPV application before randomization; * Patients already included in the study protocol at an earlier stage of the hospitalization; * Refuse to wear NPPV interface due to comfort;
Contact & Investigator
Rosanna Vaschetto, Assoc
STUDY DIRECTOR
Università degli Studi del Piemonte Orientale Amedeo Avogadro
Frequently Asked Questions
Who can join the NCT05513508 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Pressure Ulcer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05513508 currently recruiting?
Yes, NCT05513508 is actively recruiting participants. Contact the research team at rosanna.vaschetto@med.uniupo.it for enrollment information.
Where is the NCT05513508 trial being conducted?
This trial is being conducted at Novara, Italy.
Who is sponsoring the NCT05513508 clinical trial?
NCT05513508 is sponsored by Azienda Ospedaliero Universitaria Maggiore della Carita. The principal investigator is Rosanna Vaschetto, Assoc at Università degli Studi del Piemonte Orientale Amedeo Avogadro. The trial plans to enroll 478 participants.